Needle Driver and Pawl Mechanism for Circular Needle Applier

ABSTRACT

A surgical suturing device comprises a needle having a leading end, a trailing end, an arced body between the leading and trailing ends, and two steps located at antipodal positions on the body. A length of suture is connected to the needle. A needle driver reciprocates at least 180 degrees between a driven position and a returned position. The needle driver is adapted to engage the needle steps to rotate the needle in a circular path in first rotational direction. A pawl is positioned adjacent the driven position of the needle driver. The pawl is adapted to engage the needle steps to prevent the needle from rotating in a second rotational direction opposite of the first rotational direction.

RELATED APPLICATIONS

This application claims the benefit of provisional application61/736,678 filed 13-Dec.-2012 (docket number END7216USPSP), provisionalapplication 61/736,682 filed 13-Dec-2012 (docket number END7217USPSP),provisional application 61/736,690 filed 13-Dec.-2012 (docket numberEND7217USPSP), and provisional application 61/736,696 filed 13-Dec.-2012(docket number END7219USPSP), the contents of which are incorporatedherein by reference.

BACKGROUND

The present invention relates in general to surgical devices andprocedures, and more particularly to surgical suturing.

Sutures are often used in a wide variety of surgical procedures. Manualsuturing is typically accomplished by the surgeon using a fine pair ofpliers to grab and hold a suture needle, pierce the tissue with theneedle, let go of the needle, and regrasp the needle to pull the needleand accompanying suture thread through the tissues to be sutured. Suchneedles are typically curved with the suture attached to the trailingend of the needle. A variety of automated suturing devices have beenattempted to speed the process of suturing and to facilitate finesuturing or suturing during endoscopic, laparoscopic or arthroscopicsurgeries. While automated suturing devices are generally known, no onehas previously made or used a surgical suturing device in accordancewith the present invention.

BRIEF DESCRIPTION OF DRAWINGS

While the specification concludes with claims which particularly pointout and distinctly claim the invention, it is believed the inventionwill be better understood from the following description taken inconjunction with the accompanying drawings illustrating somenon-limiting examples of the invention. Unless otherwise indicated, thefigures are not necessarily drawn to scale, but rather to illustrate theprinciples of the invention.

FIG. 1 depicts a perspective view of a surgical suturing device;

FIG. 2 depicts a side view of an actuator for a surgical suturingdevice;

FIG. 3A depicts a perspective view of a shaft in a straightconfiguration;

FIG. 3B depicts a perspective view of a shaft in an articulateconfiguration;

FIG. 3C depicts a perspective view of a shaft in an articulated androtated configuration;

FIG. 4 depicts an exploded view of a shaft bearing;

FIG. 5 depicts a partial cut-away view showing the linkages in a shaft;

FIG. 6 depicts a perspective view of a cartridge receiver;

FIG. 7 depicts a perspective view of a rotary drive;

FIG. 8 depicts a perspective view of a cartridge disassembled from areceiver;

FIG. 9 depicts a perspective view of a cartridge disassembled from areceiver;

FIG. 10A depicts a perspective view of a transmission for driving aneedle at one end of its stroke;

FIG. 10B depicts a perspective view of a transmission for driving aneedle at mid-stroke;

FIG. 10C depicts a perspective view of a transmission for driving aneedle at the other end of its stroke;

FIG. 11 depicts a perspective view of a needle driver in a carriertrack;

FIG. 12 depicts a perspective view of a needle driver;

FIG. 13 depicts a cross-sectional view of the needle driver in a carriertrack and a needle in a needle track;

FIG. 14A depicts a plan view of arced needle;

FIG. 14B depicts a perspective view of arced needle;

FIG. 15A depicts a plan view of arced needle;

FIG. 15B depicts a perspective view of arced needle;

FIG. 16A depicts a plan view of a needle applier with a needle in itsretracted position and the needle driver in its returned position;

FIG. 16B depicts a plan view of a needle applier with a needle in itsextended position and the needle driver in its driven position;

FIG. 16C depicts a plan view of a needle applier with a needle in itsextended position and the needle driver in its returned position;

FIG. 16D depicts a plan view of a needle applier with a needle in itsretracted position and the needle driver in its driven position;

FIG. 17 depicts a perspective view of a cartridge receiver;

FIG. 18 depicts a perspective view of a rotary drive;

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FIG. 19 depicts a perspective view of a latch;

FIG. 20 depicts a perspective view of a cartridge disassembled from areceiver;

FIG. 21 depicts a perspective view of a cartridge disassembled from areceiver;

FIG. 22A depicts a perspective view of a transmission for driving aneedle at one end of its stroke;

FIG. 22B depicts a perspective view of a transmission for driving aneedle at mid-stroke;

FIG. 22C depicts a perspective view of a transmission for driving aneedle at the other end of its stroke;

FIG. 23A depicts a perspective view of a needle driver;

FIG. 23B depicts a perspective view of a needle driver;

FIG. 24 depicts a cross-sectional view of a needle driver in a carriertrack and a needle in a needle track;

FIG. 25A depicts a plan view of arced needle;

FIG. 25B depicts a perspective view of arced needle;

FIG. 26A depicts a plan view of arced needle;

FIG. 26B depicts a perspective view of arced needle;

FIG. 27A depicts a plan view of a needle applier with a needle in itsretracted position and the needle driver in its returned position;

FIG. 27B depicts a plan view of a needle applier with a needle in itsextended position and the needle driver in its driven position;

FIG. 27C depicts a plan view of a needle applier with a needle in itsextended position and the needle driver in its returned position;

FIG. 27D depicts a plan view of a needle applier with a needle in itsretracted position and the needle driver in its driven position;

FIG. 28 depicts a plan view of a needle applier with a needle in itsretracted position and the needle driver in its driven position;

FIG. 29A depicts a plan view of a needle applier with a needle in itsretracted position and the needle driver in its returned position;

FIG. 29B depicts a plan view of a needle applier with a needle in itsextended position and the needle driver in its driven position;

FIG. 29C depicts a perspective view of a pawl mechanism;

FIG. 29D depicts a plan view of a needle applier with a needle in itsextended position and the needle driver in its returned position;

FIG. 30A depicts a plan view of a needle applier with a needle in itsextended position and the needle driver in its driven position;

FIG. 30B depicts a perspective view of a pawl mechanism;

FIG. 31A depicts a plan view of a needle applier with a needle in itsretracted position and the needle driver in its returned position;

FIG. 31B depicts a perspective view of a pawl mechanism;

FIG. 31C depicts a cross-sectional view of a pawl mechanism;

FIG. 32 depicts a perspective view of a cartridge disassembled from areceiver;

FIG. 33 depicts a perspective view of a cartridge disassembled from areceiver.

FIG. 34 depicts an exploded view of a cartridge packaging;

FIG. 35 depicts a perspective view of a cartridge being attached to asuturing device shaft; and

FIG. 36 depicts a perspective view of a cartridge packaging.

SUMMARY

In one embodiment, a surgical suturing device has an elongate shafthaving a proximal end, a distal end, and a longitudinal axis between theproximal and distal ends. An actuator is connected to the proximal endof the elongate shaft. A circular needle applier is connected to thedistal end of the elongate shaft. The elongate shaft articulatesproximal of the circular needle applier and the circular needle applierrotates about the longitudinal axis.

The actuator may comprise a manual handle. The handle may comprise afirst input to selectively actuate the circular needle applier. Thesurgical device may further comprise a second input to selectivelyarticulate the shaft. The surgical device may further comprise a thirdinput to selectively rotate the circular needle applier about thelongitudinal axis. The elongate shaft may articulate about a joint. Thecircular needle applier may rotate about a bearing.

In another embodiment, a surgical suturing device has an elongate shafthas a proximal end, a distal end, and a longitudinal axis between theproximal and distal ends. An actuator is connected to the proximal endof the elongate shaft. A circular needle applier is on the distal end ofthe elongate shaft. The circular needle applier has an arced needle anda needle driver operatively connected to the actuator to rotate thearced needle in a circular path. A joint is positioned between theproximal and distal ends of the elongate shaft. The joint is operativelyconnected to the actuator to selectively articulate the shaft. A bearingis on the shaft positioned distally of the joint. The bearing isoperatively connected to the actuator to selectively rotate the circularneedle applier about the longitudinal axis.

In another embodiment, a surgical suturing device comprises an elongateshaft having a proximal end, a distal end, and a longitudinal axisbetween the proximal and distal ends. An actuator is connected to theproximal end of the elongate shaft. A circular needle applier isconnected to the distal end of the elongate shaft. A means articulatesthe elongate shaft, and a means rotates the circular needle applierabout the longitudinal axis. The surgical suturing device may furthercomprise a means to actuate the circular needle applier.

In another embodiment, a surgical suturing system comprises a reusableshaft and actuator. A disposable cartridge comprises a surgical needle,a length of suture connected to the surgical needle, and a needle driveroperative to engage and move the needle relative the cartridge. Thedisposable cartridge may further comprise a transmission operativelyconnected to the needle driver. The reusable shaft and actuator may beautoclavable. The reusable shaft and actuator is reusable for at least50 operations. The reusable shaft and actuator is reusable for at least150 operations. The reusable shaft and actuator is reusable for at least200 operations.

In another embodiment, a surgical suturing system comprises a reusableshaft having a proximal end and a distal end, the distal end has areceiver and a rotary drive. A reusable actuator is connected to theproximal end of the shaft. A disposable cartridge is adapted to beattached to and detached from the receiver. The cartridge comprises anarced track, an arced needle positioned in the track having a leadingend and a trailing end, a length of suture connected to the trailingend, a reciprocating needle driver operative to engage and move theneedle in the arced circular track, and a transmission operativelyconnected to the needle driver having a rotary input adapted to coupleto the rotary drive. The reusable shaft and actuator may beautoclavable.

In another embodiment, a disposable surgical needle cartridge is adaptedto be attached to and detached from a surgical suturing device. Thedisposable cartridge comprises an arced needle track, an arced needlepositioned in the needle track having a leading end and a trailing end,a length of suture connected to the needle, a reciprocating needledriver operative to engage and move the needle in the needle track, atransmission operatively connected to the needle driver, and a torsionalinterface adapted to couple the transmission to a rotary drive in thesurgical suturing device. The reciprocating needle driver andtransmission are completely encased in the cartridge. The surgicalsuturing device may be reusable. The surgical suturing device maycomprise an elongate shaft with a proximal end, a distal end, and areceiver adapted to interface with the cartridge. The disposablesurgical needle cartridge may further comprise a surgical suturingdevice.

In another embodiment, a surgical suturing system comprises a shafthaving a proximal end, a distal end, a longitudinal axis between theproximal and distal ends, and receiver on the distal end with a rotarydrive. A cartridge is selectively attachable to and detachable from thereceiver. The cartridge has a surgical needle, a length of sutureconnected to the needle, a needle driver operative to engage and movethe needle relative the cartridge, a transmission operatively connectedto the needle driver, and a torsional interface rotationally couplingthe rotary drive to the transmission.

The rotary drive may deliver a torque to the transmission through thetorsional interface about an axis transverse to the longitudinal axis ofthe shaft. The rotary drive may deliver a torque through the torsionalinterface about an axis perpendicular to the longitudinal axis of theshaft. The rotary drive may comprise a rack and pinion. The receiver maycomprise a distally extending arm axially off-set from the longitudinalaxis of the shaft. The arm may comprise a medially facing deck. Therotary drive may be positioned at least partially in the arm.

The surgical suturing system may further comprise a second distallyextending arm axially off-set from the longitudinal axis of the shaft,the arms defining a space dimensioned and adapted to receive thecartridge. The surgical suturing system may further comprise a latchoperable to lock and unlock the cartridge to the receiver. The cartridgemay be attached to and detached from the receiver by longitudinallysliding the cartridge relative to the receiver.

In another embodiment, a surgical suturing system comprises a shafthaving a proximal end, a distal end, and a longitudinal axis between theproximal and distal ends. A receiver is on the distal end of the shaft.The receiver has a pair of distally extending arms defining a space. Acartridge is selectively attachable to and detachable from the receiverby longitudinally sliding the cartridge in the space. The cartridge hasa surgical needle, a length of suture connected to the needle, a needledriver operative to engage and move the needle relative the cartridge. Alatch selectively locks and unlocks the cartridge in the receiver.

The surgical suturing system may further comprise a rotary drivepositioned at least partially in one of the arms. The surgical suturingsystem may further comprise a transmission in the cartridge operativelyconnected to the needle driver, and a torsional interface rotationallycoupling the rotary drive to the transmission.

In another embodiment, a surgical suturing system comprises a shafthaving a proximal end, a distal end, a longitudinal axis between theproximal and distal ends, and receiver on the distal end with a rotarydrive. A cartridge is selectively attachable to and detachable from thereceiver. The cartridge has a surgical needle, a length of sutureconnected to the needle, a needle driver operative to engage and movethe needle relative the cartridge, and a transmission operativelyconnected to the needle driver. A means rotationally couples the rotarydrive to the transmission. The surgical suturing system may furthercomprise a means for attaching and detaching the cartridge to thereceiver. The surgical suturing system may further comprise a means forlocking and unlocking the cartridge in the receiver.

In another embodiment, a surgical suturing device comprises an arcedneedle track. An arced needle is positioned in the needle track, theneedle having a leading end, a trailing end, a medial face, and alateral face. A length of suture is connected to the needle. An arcedcarrier track is spaced from the needle track. A reciprocating needledriver has a carrier positioned in the carrier track and a driverpositioned in the needle track and is operative to engage and move theneedle in the needle track. A transmission is operative to reciprocatethe carrier in the carrier track.

The surgical suturing device may further comprise a wall separating thecarrier track from the needle track. The surgical suturing device mayfurther comprise a slotted opening through the wall, the slotcommunicating between the carrier track and the needle track. The needledriver may extend through the slotted opening and into the needle track.The slotted opening may be adjacent the medial edge of the arced needletrack. The slotted opening may be adjacent the lateral edge of the arcedneedle track. The arced needle track and arced carrier track may beco-axial. The needle track and carrier track may be off-set along theshared axis from one another. The needle track and carrier track may beco-radial. The needle may further comprise steps dimensioned and adaptedto be engaged by the driver. The steps may be on the medial face of theneedle. The steps may be on the lateral face of the needle.

In another embodiment, a surgical suturing device comprises an arcedneedle track. An arced needle is positioned in the needle track. Theneedle has a leading end, a trailing end, a medial face, and a lateralface. A length of suture is connected to the needle. An arced carriertrack is off-set along a shared axis with the arced needle track. A wallseparates the arced needle track from the arced carrier track. The wallhas a slotted opening communicating between the arced carrier track andthe arced needle track. A reciprocating needle driver has a carrierpositioned in the arced carrier track and a driver positioned in thearced needle track operative to engage and move the needle in the needletrack. A transmission is operative to reciprocate the carrier in thecarrier track.

In another embodiment, a surgical suturing device comprises an arcedneedle track, an arced needle positioned in the needle track, and alength of suture connected to needle. A reciprocating needle driver isoperative to engage and move the needle in the needle track. A rotaryinput rotates about an axis. A link has a proximal end connected to therotary input and a distal end connected to the needle driver. Rotationof the rotary input in a first angular direction translates the needledriver in a second angular direction opposite of the first angulardirection.

The link may further comprise a longitudinal slot interposed between theproximal and distal ends, the longitudinal slot receiving a pin aboutwhich the link both longitudinally translated and pivots. The distal endmay be pivotally connected to the needle driver. The connection betweenthe needle driver and link distal end may translate in an arced pathhaving a first radius. The proximal end of the link may connect to therotary input at a second radius from the torsion drive axis, and thefirst radius may be greater than the second radius. The rotary input,link, and needle driver may have no indeterminate point. The rotaryinput may comprise a radial slot receiving a pin connected to theproximal end of the link. The surgical suturing device of may furthercomprise an elongate shaft having a proximal end and a distal end, anactuator connected to the shaft proximal end, a rotary drive operablyconnected to the actuator, and a torsional interface rotationallycoupling the rotary driver to the rotary input. The rotary drive maycomprise a rack and pinion. The rotary input may have a reciprocatingrotational motion. The needle driver may reciprocate at least 180degrees in an arced track. The needle driver may rotate the needle in acircular path at least partially defined by the needle track. The rotaryinput and needle may rotate in parallel planes.

In another embodiment, a surgical suturing device comprises a needlehaving a leading end, a trailing end, and an arced body between theleading and trailing ends. A length of suture is connected to theneedle. A needle driver is adapted to engage and rotate the needle in acircular path in a first rotational direction. A pawl is adapted toengage the trailing end of the needle to prevent the needle fromrotating in a second rotational direction opposite of the firstrotational direction.

The needle may be rotated in a plane, and the pawl may resilientlydeflect at an angle transverse to the plane. The pawl may resilientlydeflect substantially perpendicular to the plane. The needle may berotated in a plane, and the pawl may resiliently deflect substantiallyin the plane. The pawl may be positioned laterally from the needle. Thepawl may be positioned medially from the needle. The pawl may have afirst end about which the pawl pivots, and a second end having an edgethat engages the trailing end of the needle. The surgical suturingdevice may further comprise a second pawl adapted to engage the trailingend of the needle to prevent the needle from rotating in a secondrotational direction opposite of the first rotational direction. Thepawls may be antipodal to one another along the circular path. Thetrailing end may comprise a barrel receiving the suture, the barrelhaving a trailing face circumscribing the suture and the pawl may engagethe trailing face to prevent the needle from rotating in a secondrotational direction opposite of the first rotational direction. Thepawl may translates along a path perpendicular to the needle path, andthe pawl may further comprise a spring biasing the pawl in the needlepath. The pawl may further comprise a ramp adapted to be engaged by theneedle to deflect the pawl out of the needle path and allow the needleto pass the pawl. The pawl may translate along a path transverse a planedefined by the circular needle path.

In another embodiment, a surgical suturing device comprises a needlehaving a leading end, a trailing end, an arced body between the leadingand trailing ends, and two steps located at antipodal positions on thebody. A length of suture is connected to the needle. A needle driverreciprocates at least 180 degrees between a driven position and areturned position. The needle driver is adapted to engage the needlesteps to rotate the needle in a circular path in first rotationaldirection. A pawl is positioned adjacent the driven position of theneedle driver. The pawl is adapted to engage the needle steps to preventthe needle from rotating in a second rotational direction opposite ofthe first rotational direction.

The surgical device may further comprise a spring biasing the pawl inthe needle path. The pawl may further comprise a ramp adapted to beengaged by the needle and the needle driver to deflect the pawl out ofthe needle path and allow the needle and needle driver to pass the pawl.The pawl may deflect in a plane defined by the circular needle path. Thepawl may have a first end about which the pawl pivots, a second endhaving an edge that engages the needle steps, and a spring biasing thesecond end into the needle path. In the driven position the needledriver may be interposed between the pawl and the needle. The surgicaldevice may further comprise a second a pawl positioned adjacent thereturned position of the needle driver, the second pawl adapted toengage the needle steps to prevent the needle from rotating in a secondrotational direction opposite of the first rotational direction.

In another embodiment, a surgical suturing device comprises a needlehaving a leading end, a trailing end, an arced body between the leadingand trailing ends, and two steps located at antipodal positions on thebody. A length of suture is connected to the needle. A needle driverreciprocates at least 180 degrees between a driven position and areturned position. The needle driver is adapted to engage the needlesteps to rotate the needle in a circular path in first rotationaldirection. A pawl is positioned adjacent the returned position of theneedle driver. The pawl is adapted to engage the needle steps to preventthe needle from rotating in a second rotational direction opposite ofthe first rotational direction.

The surgical device may further comprise a spring biasing the pawl inthe needle path. The pawl may further comprise a proximal ramp adaptedto be engaged by the needle and the needle driver to deflect the pawlout of the needle path and allow the needle and needle driver to passthe pawl. The pawl may further comprise a distal ramp adapted to beengaged by the needle driver to deflect the pawl out of the needle pathand allow the needle driver to pass the pawl. The distal ramp may bepositioned below the needle path. The pawl may deflect in a planedefined by the circular needle path.

In another embodiment, a surgical suturing device comprises a needlehaving a leading end, a trailing end, an arced body between the leadingand trailing ends, and two steps located at antipodal positions on thebody. A length of suture connected to the needle. A needle driverreciprocates at least 180 degrees between a driven position and areturned position. The needle driver is adapted to engage the needlesteps to rotate the needle in a circular path in first rotationaldirection. A means engages the needle steps to prevent the needle fromrotating in a second rotational direction opposite of the firstrotational direction. The means may comprise a pawl. The means maycomprise a leaf spring.

In another embodiment, a surgical needle for use in a circular needleapplier comprises a leading end, a trailing end, and an arced bodybetween the leading and trailing ends. The body has a medial face and alateral face. A plurality of steps on the body are adapted to be engagedby a circular needle applier. The steps are formed by plasticallydeforming the body without removing material. A length of suture isconnected to the trailing end.

The steps may be on the medial face. The steps may be on the lateralface. The steps may be formed by a pressing operation. The steps may beformed by a rolling operation. The plurality of steps may comprise twoantipodal steps. The body may have an angular span of at least 180degrees. The arced body may comprise a substantially constant nominalradius about an origin.

In another embodiment, a surgical needle for use in a circular needleapplier comprises a leading end has a taper, a trailing end has abarrel, and an arced body extending between the taper and barrel. Thebody has a medial face, a lateral face, and plurality of steps adaptedto be engaged by a circular needle applier. The body has a substantiallyconstant cross sectional area between the taper and barrel. A length ofsuture is connected in the barrel.

The steps may be on the medial face. The plurality of steps may consistof two antipodal steps on the medial face. The steps may be on thelateral face. The plurality of steps may consist of two antipodal stepson the lateral face. The steps may be formed without removing materialfrom the body. The steps may be formed by a pressing operation. Thesteps may be formed by a rolling operation. The plurality of steps maycomprise two antipodal steps. The body may have an angular span of atleast 180 degrees.

In another embodiment, a surgical needle for use in a circular needleapplier comprises a distal leading end, a proximal trailing end, and anarced body between the leading and trailing ends. The body has a medialface and a lateral face. A first step on the body is adapted to beengaged by a circular needle applier. The first step is positioneddistally from the leading end. A longitudinal flat extends proximallyfrom the first step. The flat defines a generally D-shaped crosssectional shape in the body. A second step on the body is adapted to beengaged by a circular needle applier. The second step is positionedabout 180 degrees from the first step. A length of suture is connectedto the trailing end.

The needle may have an angular span from the leading end to the trailingend between about 210 degrees and about 270 degrees. The first andsecond steps may be located on the medial face. The first and secondsteps may be located on the lateral face. The arced body may comprise asubstantially constant nominal radius about an origin. The nominalradius may be between about 0.170 inches to about 0.210 inches. The flatmay extend proximally from the first step between about 20 degrees andabout 40 degrees. The flat may extend proximally from the first stepbetween about 100 degrees and about 150 degrees. The body may furthercomprise a ramped portion on the proximal end of the flat such that thecross sectional shape in the body transitions from a generally D-shapeto a generally circular shape. The body may further comprise a secondlongitudinal flat extending proximally from the second step, the secondflat defining a generally D-shaped cross sectional shape in the body.The second flat may extend proximally from the second step between about8 degrees and about 30 degrees. The body may further comprise a rampedportion on the proximal end of the second flat such that the sectionalshape in the body transitions from a generally D-shape to a generallycircular shape. The leading end may comprise a taper and the trailingend may have a barrel, and the body may have a substantially constantcross sectional area between the taper and barrel.

In another embodiment, packaging for a surgical needle comprises acartridge having a surgical needle and a needle driver operative toengage and move the needle relative the cartridge. The packaging has abobbin, and a length of suture connected to the needle and wound aroundthe bobbin. The packaging may further comprise an outer shell enclosingthe cartridge, bobbin, and suture. The outer shell may comprise a sheetof material folded over the cartridge and bobbin. The packaging mayfurther comprise a platform resiliently holding the cartridge. Thebobbin may be a rotating spool. The cartridge may comprise a pair ofarms defining a generally U-shaped distal end, and the packaging mayhave a block interposed between the arms. The packaging may furthercomprise a housing and a top sheet enclosing the enclosing thecartridge, bobbin, and suture.

In another embodiment, packaging for a surgical needle a housing and acartridge releasably held in the housing. The cartridge has a surgicalneedle and a needle driver operative to engage and move the needlerelative the cartridge. A bobbin is in the housing. A length of sutureis connected to the needle and wound around the bobbin. The cartridge,bobbin, and suture may be enclosed within the housing. The cartridge maycomprise a pair of arms defining a generally U-shaped distal end, andthe packaging may further comprise a block attached to the housing andextending between the arms. The housing may define a gap and thecartridge may be positioned at least partially in the gap.

In another embodiment, packaging for a surgical needle comprises ahousing having a gap. A cartridge is releasably held in the housing andextends into the gap. The cartridge has a surgical needle, a needledriver operative to engage and move the needle relative the cartridge,and a pair of arms defining a generally U-shaped distal end. A block isattached to the housing and extends between the arms. A rotary spool isin the housing. A length of suture is connected to the needle and woundaround the spool. The cartridge, bobbin, and suture are enclosed withinthe housing.

DETAILED DESCRIPTION

FIG. 1 illustrates an embodiment of a surgical suturing device. Anelongate shaft (20) has a proximal end (21), a distal end (22), and alongitudinal axis extending there between. An actuator (10) is connectedto the proximal end (21) of the shaft (20). In this embodiment theactuator (10) is a manual pistol grip handle; however, a variety ofother manual actuators could also be used, including a scissor griphandle, a syringe grip handle, endoscopic rotary knobs, and the like.The actuator (10) could also take the form of a robotic interface, suchas an DAVINCI puck, a housing comprising gears or pulleys,servomechanisms, and the like.

A circular needle applier (30) is connected to the distal end (22) ofthe shaft (20). The circular needle applier (30) rotates an arced needlein a circular path enabling a surgeon to selectively apply sutures. Thecircular needle applier (30) may be integral with the shaft (20) andactuator (10) as a unitary disposable instrument intended for a singlesurgical procedure. The circular needle applier (30) may also beintegral with the shaft (20) and actuator (10) as a reusable instrument.Optionally, the circular needle applier (30) may be embodied in adisposable cartridge, and the shaft (20) and actuator (10) may also bedisposable. In another variation, the circular needle applier (30) maybe embodied in a disposable cartridge, and the shaft (20) and actuator(10) may be reusable. Embodiments with reusable components are intendedto be cleaned, sterilized, and reused for a multiple surgicalprocedures. The preferable life cycle of a reusable instrument is atleast 50 operations, more preferably at least 150 operations, and mostpreferably at least 200 operations. Reusable components may be builtusing materials that can withstand autoclave sterilization temperaturesof at least 135 degrees Celsius, although low temperature materials canalso used with low temperature sterilization techniques known in theart.

FIG. 2 illustrates one embodiment of a manual actuator (10). A firstinput (12), shown here as a trigger that pivots between an opened andclosed position, may be used to selectively actuate the circular needleapplier (30). The trigger may be spring biased to return the trigger toits open position. A second input (14), shown here as a rotary knob, maybe used to selectively articulate the shaft (20). A third input (16),shown here as a rotary knob, may be used to selectively rotate thecircular needle applier (30) about the shaft (20). A fourth input (18),shown here as a switch, may be used to selectively attach and detach acircular needle applier (30) to the shaft (20). Naturally, the number,type, configuration, and operation of the inputs (12, 14, 16, and 18)may vary.

FIGS. 3A-B illustrate the shaft (20) articulating in response actuationof the second input (14). In this embodiment, the shaft (20) has anarticulation joint (23) to facilitate articulation. The shaft (20)includes a bearing (24) positioned distal to the joint (23). FIGS. 3B-Cillustrate the circular needle applier (30) rotating at the bearing (24)in response to actuation of the third input (16), even when the shaft(20) is articulated.

FIGS. 4-5 illustrate one example of a suitable articulation joint (23)and rotation bearing (24). The bearing (24) includes a circumferentialflange (24A) fixed to the circular needle applier (30). The flange (24A)is captured between the bearing supports (24B, 24C) such that the flange(24A) can rotate but prevent axial motion. A flexible co-axial torsiontube (28) passes through the joint (23). The torsion tube (28) has anouter sheath and an inner cable. The outer sheath of the torsion tube(28) is fixed to the flange (24A) and operatively connected to the thirdinput (16). Actuation of the third input (16) will rotate the sheath andin turn rotate circular needle applier (30). The inner cable of theco-axial torsion tube (28) passes through the circumferential flange(24A) and is operatively connected to the first input (12) to provideaxial push and pull loads to actuate the circular needle applier (30).Lateral struts (25) support the joint (23) in the shaft (20). A pin (29)connects the rods (27) to the knuckle (26) at a position off-set fromthe axis of the joint (23). The rods (27) are operatively connected tothe second input (14) to push and pull the rods (27) relative the struts(25), which will in turn articulate the shaft (20) about the joint (23).

FIG. 6 illustrates one example of a receiver (40) located on the distalend (22) of the shaft (20). The receiver (40) is dimensioned and adaptedto receive and hold a disposable cartridge containing a circular needleapplier (30). The cartridge may contain a surgical needle, a length ofsuture connected to the surgical needle, a needle driver operative toengage and move the needle relative the cartridge, and a transmissionoperatively connected to the needle driver. An axially off-set arm (41)extends distally from the shaft (20). The arm (41) has a medially facingdeck (49) with a pair of longitudinal slots (44) located below and oneither side of the deck (49). A spring loaded latch (43) is adapted toselectively lock and unlock the cartridge to the receiver (40).Optionally, latch (43) may be operatively coupled to the fourth input(18).

FIG. 7 illustrates a rotary drive having a rack (45) and pinion (47) ispositioned partially in the arm (41) and below the deck (49). The innercable of the co-axial torsion tube (28) is connected to the proximal end(46) of the rack (45) such that closing the trigger of the first input(12) will pull the rack (45) proximally, and opening the trigger of thefirst input (12), which may be by virtue of a spring return, will pushthe rack (45) distally. Thus, actuating the first input (12) willrotationally reciprocate the pinion (47). The key (48) translates thereciprocating rotation to the transmission in the cartridge.

FIGS. 8-9 illustrate one example of a disposable cartridge (50) adaptedto be attached to the receiver (40). The cartridge (50) may be slidproximally onto the receiver (40) so the two decks (49, 59) are paralleland facing one another until the latch (43) engages the recess (53). Thecartridge (50) in encased by a lower housing (51), an upper housing(52), and a needle cover (90). The lower housing (51) has a pair oflongitudinal slots (54) dimensioned to interface and mate with the slots(44). The slot (58) is dimensioned to receive the key (48) while thecartridge (50) is being slid onto the receiver (40). When the cartridge(50) is fully seated into the receiver (40), the pinion (47) is axiallyaligned with rotary input (67), which forms part of the transmission inthe cartridge (50), and the key (48) is positioned in the slot (68)thereby providing a torsional interface that rotationally couples thepinion (47) and rotary input (67).

Thus, the rotary drive in the shaft (20) delivers an operational torqueto the transmission in the cartridge (50) about an axis perpendicular tothe longitudinal axis of the shaft (20). The operational torque couldalso be delivered along an axis parallel or in line with thelongitudinal axis of the shaft (20), or at another transverse anglerelative the longitudinal axis of the shaft (20). Further, othertorsional interfaces known in the art other than the key (48) and slot(68) embodiment may be used, such as a cross, star, square, spline, andthe like.

FIGS. 10A-C illustrate one example of a transmission in the cartridge(50) for driving a needle in a circular path. A needle driver (70)reciprocates in the arced carrier track (55) and is operative to engageand rotate an arced needle. A link (60) connects the rotary input (67)to the needle driver (70). The pin (71) pivotally connects the distalend of the link (60) to the needle driver (70). The rotary input (67)has a slot (68) that mates with the key (48) so as to receive thereciprocating rotation from the rotary drive. The rotary input (67) hasa radially extending arm (65) with a radial slot (66). The pin (64) ispositioned in the slot (66) connecting the proximal end of the link (60)to the rotary input (67). The slot (66) rotationally constrains the pin(64) to the arm (65) while accommodating some relative radial movement.The link (60) has a longitudinal slot (61) receiving the fixed pin (62)about which the link (60) both longitudinally translates and pivots. Thepins (71, 62) are co-planar, but pin (66) lies in an off-set plane. Thelink (60) includes a bent section (63) to accommodate the off-set. Otherthan the torsional interface, which in this embodiment comprises theface of the rotary input (67) with the slot (68), the entiretransmission is completely encased within cartridge (50).

FIG. 10A illustrates the needle driver (70) positioned at one end of itsstroke in the carrier track (55). As shown in FIG. 10B, counterclockwiserotation of the rotary input (67) will translate the needle driver (70)clockwise along the carrier track (55). The radius of rotation of thepin (71) is greater than the radius of rotation of the pin (64). Asshown in FIG. 10C, continued counterclockwise rotation of the rotaryinput (67) will continue to translate the needle driver (70) clockwiseuntil it reaches the other end of its stroke in the carrier track (55).The rotary input (67), link (60), and needle driver (70) have noindeterminate point, so rotation of the rotary input (67) will cause theneedle driver (70) to translate in the opposite rotational directionthroughout the stroke without binding.

The sequence can be reversed by rotating the rotary input (67)clockwise, which will translate the needle driver (70) counterclockwisein the carrier track (55). Thus, actuation of the first input (12) willcause the needle driver (70) to reciprocate back and forth along thecarrier track (55).

FIGS. 11-13 illustrate one example of a needle driver (70) and itsoperation. The upper housing (52) has an arced needle track (56) and anarced carrier track (55). In this embodiment, the needle track (56) andcarrier track (55) each have a nominal radius of curvature originatingfrom a common axis. Therefore, the needle track (56) and carrier track(55) are co-axial. Also in this embodiment, the tracks (55, 56) at leastpartially overlap one another in the radial dimension, so they are alsoco-radial. The tracks (55, 56) are off-set along the shared axis fromone another with a wall separating the tracks (55, 56). A slot (57)opens through the wall and provides communication between the carriertrack (55) and the needle track (56). In this embodiment the slot (57)opens adjacent the lateral edge of the needle track (56).

The needle driver (70) has a carrier (75) dimensioned to slideably fitin the carrier track (55). In this embodiment, the carrier (75) has acurved body matching the arc of the carrier track (55). The pin (71)extends from the carrier (75) to engage the link (60). The needle driver(70) extends through the slot (57) and into the needle track (56). Thecarrier (75) has a flange (77) dimensioned to fit in the slot (57). Adriver (76) is attached to the carrier (75) and is positioned in theneedle track and operative to engage and move the needle (80) in theneedle track (56). The driver (76) is an L-shaped metal blade with oneleg (76C) sandwiched between two pieces that form the carrier (75). Thedriver (76) may deflect as a cantilevered leaf spring laterally from theflange (77), and may also resiliently bias to engage the lateral face ofthe needle (80). In this embodiment the driver (76) has a drive face(76A) and a return face (76B). The drive face (76A) has an edge that isoperative to engage steps on the needle (80) during the drive stroke.When so engaged, the needle (80) will slide in the needle track (56) inunison with the driver (70). The return face (76B) is ramped tofacilitate the driver (76) sliding over the needle (80) on the returnstroke.

The lower housing (51) constrains the link (60) to engage the pin (71)and also constrains the carrier (75) in the carrier track (55). Theneedle cover (90) constrains the needle (80) in the needle track (56).The needle cover (90) also defines a window (91) along the length of theneedle track (56). The window (91) is dimensioned to receive the suture.As the needle (80) is rotated in the needle track (56), the suture mayextend out through the window (91). However, the window (91) isdimensioned smaller than the needle (80) so as to constrain the needle(80) in the needle track (56).

FIGS. 14A-B illustrates one embodiment of a needle (80) having a distalleading end (81) with a sharp tapered tip (83). A variety of geometriescould be employed at the leading end (81), including conical, bladed,blunt, cutting tips, taper-cut tips, and the like. The proximal trailingend (82) has a tubular barrel (84) that fixedly receives a length ofsuture (89). A trailing face (88) circumscribes the suture (89). Avariety of different types of suture (89) may be employed, includingbraided, monofilament, and barbed suture using a variety of materials,including polyglactin (e.g., VICRYL), poliglecprone (e.g., MONOCRYL),polydioxanone (e.g., PDS), surgical gut, polyester (e.g., ETHIBOND),silk (e.g. PERMA-HAND), polypropylene (e.g., PROLENE), other absorbableor non-absorbable materials, and the like.

The angular span between the leading end (81) and trailing end (82) maybe between about 210 degrees and about 270 degrees. An arced body (85)extends between the tapered tip (83) and the barrel (84). The body (85)may arc at a substantially constant radius of curvature. The nominalradius of curvature may be between about 0.170 inches to about 0.210inches, preferably between about 0.180 inches to about 0.205 inches, andmore preferably between about 0.190 inches to about 0.200 inches;however, other dimensions are also possible.

A distal step (86A) is positioned on the lateral face of the body (85).The distal step (86A) may be located between about 20 degrees and about30 degrees from the leading end (81). A proximal step (87A) ispositioned on the lateral face of the body (85). The proximal step (87A)is about 180 degrees from the distal step (86A). Therefore, the steps(86A, 87A) are located at antipodal locations on the needle (80). Thesteps (86A, 87A) are adapted to be engaged by the driver (76) of theneedle driver (70). The height of the steps (86A, 87A) are preferablybetween about 0.003 inches and about 0.010 inches, but other dimensionsare also possible. Flats (86B, 87B) extend distally from the steps (86A,87A) and define a generally D-shaped cross sectional shape in the body(85). The distal flat (86B) has an angular span between about 20 degreesand about 40 degrees from the distal step (86A). The proximal flat (87B)has an angular span between about 8 degrees and about 30 degrees fromthe distal step (87A). The flats (86B, 87B) may facilitate reducing thedimensional interference between the needle (80) and driver (76) duringthe return stroke of the needle driver (70). Ramps (86C, 87C) arelocated adjacent the proximal ends the flats (86B, 87B) such that thecross-sectional shape of the body (85) transitions from a generallyD-shape to a generally circular shape. The ramps (86C, 87C) reduce thelikelihood of the driver (76) snagging on the needle (80) during thereturn stroke of the needle driver (70).

The step, flat, and ramp features (86A, 87A, 86B, 87B, 86C, 87C) may bemade by plastically deforming the body (85). For instance, a die can beused in a pressing or rolling operation on a straight wire stock to formthe features on the body (85). Then the straight stock can be bent toits arced shape. While the cross-sectional shape of the body (85) willchange along its length, the cross-sectional area between the taper (83)and the barrel (84) will remain substantially constant. This isadvantageous over notched needle designs where material is being removedto create notches, such as in a cutting or grinding operation, resultingin a weaker needle. Furthermore, plastically forming features in thebody (85) is more reliable and reproducible, and capable of fasterproduction.

FIGS. 15A-B illustrates another embodiment of needle (80) substantiallythe same as in FIGS. 14A-B; however, the distal flat (86B) has anangular span between about 100 degrees and about 150 degrees from thedistal step (86A).

FIGS. 16A-D illustrate one embodiment of a circular needle applier (30)rotating an arced needle (80) in a circular path. The suture has beenhidden in the figures to better illustrate device operation. A pair ofarms (94, 95) define a generally U-shaped distal end on the circularneedle applier (30). The needle track (56) has an exit port (92) in arm(94) and an entrance port (93) in arm (95). The leaf springs (96, 97)allow the needle (80) to rotate counterclockwise, but prevent the needle(80) from rotating clockwise. Leaf spring (97) extends into the needletrack (56) and resiliently deflects laterally when engaging the lateralface of the needle (80), thus allowing counterclockwise motion. Leafspring (96) extends into the needle track (56) and resiliently deflectsmedially when engaging the medial face of the needle (80), thus allowingcounterclockwise motion. But when the needle (180) passes one of theleaf springs (96, 97), it will deflect into the path to interfere andengage the trailing face (88), thus preventing the needle (80) fromrotating clockwise.

FIG. 16A shows the device in its initial position. The needle (80) is inits retracted position and completely contained in the needle track(56). The needle driver (70) has a reciprocating stroke between areturned position and a driven position. In this figure, the driver (76)is in its returned position in arm (95). The driver (76) is adjacent theproximal step (87A). Leaf spring (96) resiliently engages the needle(80), while leaf spring (97) is adjacent the trailing face (88)preventing the needle (80) from rotating clockwise.

When the first input (12) is depressed closing the trigger, the needledriver (70) will be actuated through its drive stroke where it isrotated at least about 180 degrees counterclockwise to the drivenposition as shown in FIG. 16B. During the drive stroke, the driver (76)engages the proximal step (87A) and will in unison rotate the needle(80) about 180 degrees to its extended position. The needle (80) willspan across the arms (94, 95) between the exit port (92) and theentrance port (93). Tissue interposed between the arms (94, 95) will bepieced by the leading end (81) of the needle (80).

When the first input (12) is released and the spring return opens thetrigger, the needle driver (70) reciprocates through its return strokewhere it is rotated about 180 degrees clockwise back to the returnposition shown in FIG. 16C. During the return stroke the driver (76)slides over the needle (80) and the leaf spring (96) engages thetrailing face (88) preventing the needle (80) from rotating clockwise.The driver (76) is adjacent the distal step (86A).

When the first input (12) is depressed again closing the trigger, theneedle driver (70) will again be actuated through its drive stroke whereit is rotated about 180 degrees counterclockwise to the driven positionas shown in FIG. 16D. During the drive stroke, the driver (76) engagesthe distal step (86A) and will in unison rotate the needle (80) about180 degrees back to its retracted position. The suture will follow theneedle (80) and be threaded through the pieced tissue.

When the first input (12) is again released and the spring return opensthe trigger, the needle driver (70) again reciprocates through itsreturn stroke where it is rotated about 180 degrees clockwise back toits returned position as shown in FIG. 16A. During the return stroke thedriver (76) slides over the needle (80) and the leaf spring (97) engagesthe trailing face (88) preventing the needle (80) from rotatingclockwise. Thus, the needle (80) is driven in a complete circular path.The sequence may be repeated as needed by the surgeon to achieve thedesired suturing task.

FIGS. 17-21 illustrate another embodiment of a receiver (140) located onthe distal end (22) of the shaft (20). The receiver has an axiallyoff-set lower arm (141) and an axially off-set upper arm (142), eachhaving a longitudinal slot (144). A spring loaded latch (143) is adaptedto selectively lock and unlock the cartridge (150) in the receiver(140). A rack (145) and pinion (147) rotary drive is positioned in thelower arm (141). The inner cable of the co-axial torsion tube (28) isconnected to the proximal end (146) of the rack (145). The rack (145) isbent to accommodate the axial off-set of the lower arm (141). The key(148) mates with the slot (168) to translate the reciprocating rotationof the pinion (147) to the rotary input (168) in the cartridge (150).

The disposable cartridge (150) is adapted to be attached to the receiver(140). The cartridge (150) may be slid proximally between the arms (141,142) of the receiver (140) until the latch (143) engages the step (152).The step (154) mates with the longitudinal slot (144) in the lower arm(141), and the step (152) mates with the longitudinal slot (144) in theupper arm (142). The slot (158) is dimensioned to receive the key (148)while the cartridge (150) is being slid onto the receiver (140). Whenthe cartridge (50) is fully seated into the receiver (140), the pinion(147) is axially aligned with rotary input (167) and the key (148) ispositioned in the slot (168) thereby rotationally coupling the rotarydrive to the rotary input (167).

FIGS. 22A-C illustrate one example of a transmission in the cartridge(150) for driving a needle in a circular path. A needle driver (170)reciprocates in the arced carrier track (155). A straight link (160)connects the rotary input (167) to the needle driver (170). The pin(171) pivotally connects the distal end of the link (160) to the needledriver (170). The rotary input (167) a radial slot (166). The pin (164),hidden from view below the link (160), is positioned in the slot (166)to connect the proximal end of the link (160) to the rotary input (167).The slot (166) rotationally constrains the pin (164) while accommodatingsome relative radial movement. The link (160) has a longitudinal slot(161) receiving the fixed pin (162) about which the link (160) bothlongitudinally translates and pivots. The needle driver (170) and rotaryinput (167) are co-planar. A tooth (165) engages stops in the cartridgeto limit the rotational stoke of the rotary input (167).

FIG. 22A illustrates the needle driver (170) positioned at one end of itstroke in the carrier track (155). As shown in FIG. 22B, clockwiserotation of the rotary input (167) will translate the needle driver(170) counterclockwise along the carrier track (155). As shown in FIG.22C, continued clockwise rotation of the rotary input (167) willcontinue translate the needle driver (170) counterclockwise until itreaches the other end of its stroke in the carrier track (155). Therotary input (167), link (160), and needle driver (170) have noindeterminate point, so rotation of the rotary input (167) will causethe needle driver (170) to translate in the opposite rotationaldirection throughout the stroke without binding. The sequence can bereversed by rotating the rotary input (167) counterclockwise, which willtranslate the needle driver (170) clockwise in the carrier track (55).

FIG. 23A illustrates one embodiment of a needle driver (170). A carrier(175) is dimensioned to slideably fit in the carrier track (155). Thecarrier (175) may be a monolithic component with an arced shaped. Thepin (171) extends from the carrier (175). The driver (176) extends fromthe carrier (175) through the slot (157) and into the needle track(156). The driver (176) is an L-shaped metal blade with one leg (176C)having a hole that fits over the pin (171) and is seated against thecarrier (175). The driver (176) has a drive face (176A) and a returnface (176B). In this embodiment, the drive face (176A) and return face(176B) are generally co-planar and symmetrical. FIG. 23B shows anotherembodiment where the drive face (176A) is bent toward the needle (180).

As shown in FIG. 24, the needle track (156) and carrier track (155) areco-axial and co-radial. The tracks (155, 156) are off-set along theshared axis from one another with a wall separating the tracks (155,156). A slot (157) opens through the wall and provides communicationbetween the carrier track (155) and the needle track (156). In thisembodiment the slot (157) opens adjacent the medial edge of the needletrack (156). The needle (180) slideably fits in the needle track (156)and the carrier (175) slideably fits in the carrier track (155). Thedriver (176) extends through the slot (157) and into the needle track(156). The driver (176) is arranged as a cantilever leaf springresiliently engaging the medial face of the needle (180). As the needle(180) is rotated in the needle track (156), the suture may extend outthrough the window (191).

FIGS. 25A-B illustrates an embodiment of a needle (180) having a distalleading end (181) with a sharp tapered tip (183). The proximal trailingend (182) has a tubular barrel (184) that fixedly receives a length ofsuture (189). A trailing face (188) circumscribes the suture (189). Anarced body (185) extends between the tapered tip (183) and barrel (184).A distal step (186A) is positioned on the medial face of the body (185).The distal step (186A) may be located between about 20 degrees and about30 degrees from the leading end (181). A proximal step (187A) ispositioned on the medial face of the body (185) about 180 degrees fromthe distal step (186A). The steps (186A, 187A) are adapted to be engagedby the driver (176) of the needle driver (170). Flats (186B, 187B)extend distally from the steps (186A, 187A) and define a generallyD-shaped cross sectional shape in the body (185). The distal flat (186B)has an angular span between about 20 degrees and about 40 degrees fromthe distal step (186A). The proximal flat (187B) has an angular spanbetween about 8 degrees and about 20 degrees from the distal step(187A). Ramps (186C, 187C) are located adjacent the proximal ends theflats (186B, 187B) such that the cross-sectional shape of the body (185)transitions from a generally D-shape to a generally circular shape. Thesteps (186A, 187A), flats (186B, 187B), and ramps (186C, 187C) may bemade by plastically deforming the body (185). In addition to theadvantages discussed above, the process of plastically forming thedistal step (186A) may partially bend the tapered tip (183) medially,which facilitates locating the leading end (181) along the desiredradius of curvature when the straight stock is bent to its arced shape.

FIGS. 26A-B illustrates another embodiment of needle (180) substantiallythe same as in FIGS. 25A-B; however, the distal flat (186B) has anangular span between about 120 degrees and about 150 degrees from thedistal step (186A).

FIGS. 27A-D illustrate one embodiment of a circular needle applier (30)rotating an arced needle (180) in a circular path. The suture has beenhidden in the figures to better illustrate device operation. A pair ofarms (194, 195) define a generally U-shaped distal end on the circularneedle applier (30). The needle track (156) has an exit port (192) inarm (194) and an entrance port (193) in arm (195). The leaf springs(196, 197) allow the needle (180) to rotate counterclockwise, butprevent the needle (180) from rotating clockwise. Leaf spring (197)extends into the needle track (156) and resiliently deflects laterallywhen engaging the lateral face of the needle (180). Leaf spring (196)extends into the needle track (156) and resiliently deflects laterallywhen engaging the lateral face of the needle (180). The leaf springs(196, 197) are spaced about 180 degrees from one another.

FIG. 27A shows the device in its initial position. The needle (180) isin its retracted position and completely contained in the needle track(156). The needle driver (170) is in its returned position in arm (195).The driver (176) is adjacent the proximal step (187A). Leaf spring (197)is adjacent the trailing face (188) preventing the needle (180) fromrotating clockwise.

When the needle driver (170) is actuated through its drive stroke, it isrotated about 180 degrees counterclockwise to the driven position asshown in FIG. 27B. During the drive stroke, the driver (176) engages theproximal step (187A) and will in unison rotate the needle (180) about180 degrees to its extended position. The needle (180) will span acrossthe arms (194, 195) between the exit port (192) and the entrance port(193). Tissue interposed between the arms (194, 195) will be pieced bythe leading end (181) of the needle (180).

When the needle driver (170) reciprocates through its return stroke, itis rotated about 180 degrees clockwise back to the return position shownin FIG. 27C. During the return stroke the driver (176) slides over theneedle (180) and the leaf spring (196) engages the trailing face (188)preventing the needle (180) from rotating clockwise.

When the needle driver (170) is actuated through its drive stroke, it isrotated about 180 degrees counterclockwise to the driven position asshown in FIG. 27D. During the drive stroke, the driver (176) engages thedistal step (186A) and will in unison rotate the needle (180) about 180degrees back to its retracted position. The suture will follow theneedle (180) and be threaded through the pierced tissue.

When the needle driver (170) reciprocates through its return stroke, itis rotated about 180 degrees clockwise back to its returned position asshown in FIG. 27A. During the return stroke the driver (176) slides overthe needle (180) and the leaf spring (197) engages the trailing face(188) preventing the needle (80) from rotating clockwise. Thus, theneedle (180) is driven in a complete circular cycle.

FIG. 28 illustrates a variation using pawls (206, 207) to allow theneedle (180) to rotate counterclockwise, but prevent the needle (180)from rotating clockwise. Each pawl (206, 207) is generally “tear-drop”shaped having a rounded end and a pointed end with an edge. The pawls(206, 207) pivot around the rounded end in the same plane as the needle(180) such that the pointed end can rotate in and out of the needletrack (156). Spring (206B, 207B) bias the pointed ends medially into theneedle track (156). The pointed ends extend into the needle track (156)and resiliently deflect laterally when engaging the lateral face of theneedle (180), thus allowing counterclockwise motion. But when the needle(180) passes one of the pawls (206, 207), the pointed ends will deflectmedially into the path to interfere and engage the trailing face (188),thus preventing the needle (180) from rotating clockwise.

FIGS. 29A-D illustrate another embodiment of a circular needle applier(30). Pawls (216, 217) allow the needle (180) to rotate counterclockwisein the needle track (156), but prevent the needle (180) from rotatingclockwise. In this embodiment, pawls (216, 217) engage and act on thesame features of the needle (180) as the needle driver (170). Whileillustrated with two pawls (216, 217), it will be appreciated that theirfunction is redundant and the device can operate with only one of thepawls (216, 217) present.

Pawl (216) is generally aligned with the driven position of the driver(176). Pawl (216) translates transverse to the needle (180) path and inthe plane of the needle (180). A spring (216B) biases the pawl (216)laterally into the needle track (156). As the needle (180) rotatescounterclockwise, the needle (180) or driver (176) will engage the ramp(216A) to deflect the pawl (216) medially, thus allowingcounterclockwise motion. Pawl (217) is generally aligned with thereturned position of the driver (176). Pawl (217) can translate radiallyin the plane of the needle (180). A spring (217B) biases the pawl (217)laterally into the needle track (156). As the needle (180) rotatescounterclockwise, the needle (180) or driver (176) engages the ramp(217A) to deflect the pawl (217) medially, thus allowingcounterclockwise motion.

FIG. 29A shows the device in its initial position. The needle (180) isin its retracted position and the needle driver (170) is in its returnedposition. Pawl (216) is adjacent the distal step (186A) and pawl (217)is adjacent the proximal step (187A), both preventing clockwiserotation.

When the needle driver (170) is actuated through its drive stroke, it isrotated about 180 degrees counterclockwise to the driven position asshown in FIG. 29B. During the drive stroke, the driver (176) engages theproximal ramp (217A) and medially displace the pawl (217), then engagesthe proximal step (187A), and then in unison rotates the needle (180)about 180 degrees to its extended position. In the extended position,the pawl (217) is adjacent the distal step (186A) preventing the needle(180) from rotating clockwise. As the driver (176) approaches the drivenposition, the driver (176) will engage the ramp (216A) and mediallydisplace the pawl (216). In the driven position, the driver (176) willremain interposed between the pawl (216) and the needle (180).

When the needle driver (170) reciprocates through its return stroke, itis rotated about 180 degrees clockwise back to the return position shownin FIG. 29D. As the driver (176) passes, the pawl (216) deflectsadjacent the proximal step (187A) preventing the needle (180) fromrotating clockwise. As illustrated in the FIG. 29C, the pawl (217) has adistal ramp (217C) positioned below needle steps (186A, 187A). Forinstance, the distal ramp (217C) may be positioned in the slot (157)while the proximal ramp (217A) is positioned in the needle track (156).During the return stroke, the driver (176) engages the proximal ramp(216C) and medially displaces the pawl (216). As the driver (176)passes, the pawl (217) deflects adjacent the distal step (186A)preventing the needle (180) from rotating clockwise.

The sequence can then be repeated to drive the needle (180) about 180degrees to is retracted position.

FIGS. 30A-B illustrate a variation of pawls (226, 227) that engage andact on the same features of the needle (180) as the needle driver (170).While illustrated with two pawls (226, 227), it will be appreciated thattheir function is redundant and the device can operate with only one ofthe pawls (226, 227) present.

Pawl (226) is generally aligned with the driven position of the driver(176). Pawl (226) is generally “tear-drop” shaped and functions similarto the pawls (206, 207). A torsional spring (226B) biases the pointedend laterally into the needle track (156). As the driver (176)approaches the driven position, the driver (176) will engage andmedially displace the pointed end of the pawl (226). In the drivenposition, the driver (176) will remain interposed between the pawl (226)and the needle (180). When the needle driver (170) reciprocates throughits return stroke, the driver (176) passes and the pawl (226) deflectsadjacent the proximal step (187A) preventing the needle (180) fromrotating clockwise. Pawl (226) may be substituted for a leaf springsimilar in construction as leaf springs (96, 97) that would engage andact on the same features of the needle (180) as the needle driver (170).

Pawl (227) is biased laterally into the needle track (156) and functionssimilar to the pawl (217) in its sequence of engagement between thedriver (176) and needle (180). The proximal ramp (227A) is positioned inthe needle track (156) and allows the needle (180) and driver (176) topass as they rotate counterclockwise. The distal ramp (227C) ispositioned in the slot (157) so that during the return stroke, thedriver (176) engages the proximal ramp (216C) and medially displaces thepawl (216).

FIGS. 31A-C illustrate another embodiment of pawls (236, 237) that allowthe needle (180) to rotate counterclockwise, but prevent the needle(180) from rotating clockwise. Pawl (236) is generally oval shaped withone end partially angled to an edge. The pawl (236) pivots around therounded end in the same plane as the needle (180) such that the edge canrotate in and out of the needle track (156). A torsional spring biasesthe edge medially into the needle track (156). The pawl (236) functionssimilar to the pawl (206) in its sequence of engagement needle (180) andthe trailing face (188).

Pawl (237) is located in the arm (195) adjacent the entrance port (193).The pawl (237) is positioned below the needle track (156) and translatesat an angle transverse, and optionally perpendicular, to the plane ofthe needle (180). A spring (237B) biases the pawl (237) upward into theneedle track (156). As the needle (180) rotates counterclockwise, theneedle (180) engages the ramp (237A) to deflect the pawl (237) downward,thus allowing counterclockwise motion. But when the needle (180) passesthe pawl (237), it will deflect into the path to interfere and engagethe trailing face (188), thus preventing the needle (180) from rotatingclockwise.

FIG. 32 illustrates another embodiment of a cartridge (250) and receiver(240). The cartridge (250) may be similar to any of the prior describedcartridges, and contains a surgical needle, a length of suture connectedto the surgical needle, a needle driver operative to engage and move theneedle relative the cartridge, and a transmission operatively connectedto the needle driver. The receiver (240) has an axially off-set lowerarm (141) and an axially off-set upper arm (142). The lower arm (242)extends more distally than the upper arm (241). The lower arm (242) hasa longitudinal ridge (244) that mates with a corresponding groove (notshown) on the cartridge (250). A rotary drive mechanism is located inthe lower arm (242). A pair of barbed prongs (253) extend from thecartridge (250). The cartridge (250) is attached to the receiver (240)by longitudinally sliding the cartridge (250) between the arms (241,242) until the prongs (253) seat in the holes (243), thus locking thecartridge (250) in the receiver (240). The cartridge (250) can beunlocked and removed by squeezing the grips (254), which will mediallydeflect the prongs (253) until they disengage from the holes (243), atwhich point the cartridge (250) can be pulled from the receiver (240).

FIG. 33 illustrates another embodiment of a cartridge (350) and receiver(340). The cartridge (350) may be similar to any of the prior describedcartridges, and contains a surgical needle, a length of suture connectedto the surgical needle, a needle driver operative to engage and move theneedle relative the cartridge, and a transmission operatively connectedto the needle driver. The receiver (340) has a longitudinal deck throughwhich a key (348) translates the reciprocating rotation of a rotarydrive to the transmission in the cartridge (350). A pair of spaced apartflanges (341) are adjacent the distal end of the deck (349). Each flange(341) has a pin hole (342). The cartridge (350) is attached to thereceiver (340) by snapping the pins (353) into the pin holes (342). Thecartridge (350) is then rotated about the pins (353) until it engagesthe deck (349). A detent mechanism (343) engages a matching recess inthe cartridge (350) to lock the cartridge (350) in the receiver (340).The cartridge (350) can be unlocked and removed by reversing thesequence.

FIG. 34 illustrates an embodiment of packaging (400) for a cartridge(450). The cartridge (450) may be similar to any of the prior describedcartridges, and contains a surgical needle, a length of suture (489)connected to the surgical needle, a needle driver operative to engageand move the needle relative the cartridge, and a transmissionoperatively connected to the needle driver. The packaging (400) has anouter shell comprising a housing (402) and a top sheet (401). The needlein the cartridge (450) is in its refracted position. The cartridge (450)is releasably held by arms (405). The block (406) is positioned in theU-shaped distal end on the cartridge (450) and prevents the needle fromexiting the cartridge (450). The cartridge (450) extends into the gap(404). The suture (489) extends from the cartridge (450) and is coiledaround the bobbin (408), shown here as a dynamic spool that can rotateabout the axle (407). The bobbin (408) can take alternatively take theform of a static bobbin, such as pegs or a track, around which thesuture (489) can be coiled.

As shown in FIG. 35, the packaging (400) facilitates assembly of thecartridge (400) onto a suturing device (420). The packaging (400)provides an ergonomically friendly format to handle, align, and assemblythe cartridge (400) onto the shaft (420) of a suturing device, whilekeeping the needle safely isolated from the user. Once assembled andattached, withdrawing the shaft (420) will pull the cartridge (400) frompackaging (400) and the suture (489) will reel out from the bobbin (408)and be ready for use.

FIG. 36 illustrates another embodiment of packaging (500) for acartridge (550). The cartridge (550) may be similar to any of the priordescribed cartridges, and contains a surgical needle, a length of suture(589) connected to the surgical needle, a needle driver operative toengage and move the needle relative the cartridge, and a transmissionoperatively connected to the needle driver. The cartridge (550) isreleasably held on the platform (503) between the arms (505) with theblock (506) inserted into the U-shaped distal end on the cartridge(550). The suture (589) extends from the cartridge (550) and is coiledaround the bobbin (508). The packaging (500) has an outer shell (501) inthe form of plastic or paper sheet. The small flap (502) is folded overthe bobbin (508) and cartridge (550), large flap (503) is folded overthe small flap (502), thus enclosing the cartridge (550), bobbin (508),and suture (589).

Having shown and described various embodiments and examples of thepresent invention, further adaptations of the methods and devicesdescribed herein can be accomplished by appropriate modifications by oneof ordinary skill in the art without departing from the scope of thepresent invention. Several of such potential modifications have beenmentioned, and others will be apparent to those skilled in the art. Forinstance, the specific materials, dimensions, and the scale of drawingswill be understood to be non-limiting examples. Accordingly, the scopeof the present invention should be considered in terms of the followingclaims and is understood not to be limited to the details of structure,materials, or acts shown and described in the specification anddrawings.

1. A surgical suturing device, comprising: a needle comprising a leadingend, a trailing end, an arced body between the leading and trailingends, and two steps located at antipodal positions on the body; a lengthof suture connected to the needle; a needle driver that reciprocates atleast 180 degrees between a driven position and a returned position, theneedle driver adapted to engage the needle steps to rotate the needle ina circular path in first rotational direction; and a pawl positionedadjacent the driven position of the needle driver, the pawl adapted toengage the needle steps to prevent the needle from rotating in a secondrotational direction opposite of the first rotational direction.
 2. Thesurgical device of claim 1, further comprising a spring biasing the pawlin the needle path.
 3. The surgical device of claim 2, wherein the pawlfurther comprises a ramp adapted to be engaged by the needle and theneedle driver to deflect the pawl out of the needle path and allow theneedle and needle driver to pass the pawl.
 4. The surgical device ofclaim 3, wherein the pawl deflects in a plane defined by the circularneedle path.
 5. The surgical device of claim 1, wherein the pawl has afirst end about which the pawl pivots, a second end having an edge thatengages the needle steps, and a spring biasing the second end into theneedle path.
 6. The surgical device of claim 1, wherein in the drivenposition the needle driver is interposed between the pawl and theneedle.
 7. The surgical device of claim 1, further comprising a second apawl positioned adjacent the returned position of the needle driver, thesecond pawl adapted to engage the needle steps to prevent the needlefrom rotating in a second rotational direction opposite of the firstrotational direction.
 8. A surgical suturing device, comprising: aneedle comprising a leading end, a trailing end, an arced body betweenthe leading and trailing ends, and two steps located at antipodalpositions on the body; a length of suture connected to the needle; aneedle driver that reciprocates at least 180 degrees between a drivenposition and a returned position, the needle driver adapted to engagethe needle steps to rotate the needle in a circular path in firstrotational direction; and a pawl positioned adjacent the returnedposition of the needle driver, the pawl adapted to engage the needlesteps to prevent the needle from rotating in a second rotationaldirection opposite of the first rotational direction.
 9. The surgicaldevice of claim 8, further comprising a spring biasing the pawl in theneedle path.
 10. The surgical device of claim 9, wherein the pawlfurther comprises a proximal ramp adapted to be engaged by the needleand the needle driver to deflect the pawl out of the needle path andallow the needle and needle driver to pass the pawl.
 11. The surgicaldevice of claim 10, wherein the pawl further comprises a distal rampadapted to be engaged by the needle driver to deflect the pawl out ofthe needle path and allow the needle driver to pass the pawl.
 12. Thesurgical device of claim 11, wherein the distal ramp is positioned belowthe needle path.
 13. The surgical device of claim 9, wherein the pawldeflects in a plane defined by the circular needle path.
 14. A surgicalsuturing device, comprising: a needle comprising a leading end, atrailing end, an arced body between the leading and trailing ends, andtwo steps located at antipodal positions on the body; a length of sutureconnected to the needle; a needle driver that reciprocates at least 180degrees between a driven position and a returned position, the needledriver adapted to engage the needle steps to rotate the needle in acircular path in first rotational direction; and a means for engagingthe needle steps to prevent the needle from rotating in a secondrotational direction opposite of the first rotational direction.
 15. Thesurgical suturing device of claim 14, wherein the means for engagingcomprises a pawl.
 16. The surgical suturing device of claim 14, whereinthe means for engaging comprises a leaf spring.